This document provides indications for how to apply the in vitro diagnostic medical devices (IVDR) provisions related to expert panels and EU reference laboratories (EURLs) before the IVDR application date, i.e. 26 May 2022, as...
This rolling plan contains a list of key activities that the Commission has carried out or intends to carry out in preparation for the implementation of Regulation 2021/2282 on Health Technology Assessment. The plan is...
The EMA released the presentation materials, and the video recording of the Clinical Trials Regulation (CTR) Collaborate Stakeholder meeting held the 11 September. The Clinical Trials Coordination Group (CTCG), supported by the ACT EU Priority...
A new revision of the guidance available to applicants, marketing authorisation holders and notified bodies of medical devices has been published today. This question-and-answer document provides practical considerations on the implementation of the medical devices...
The documents sets out frequently-asked ‘questions and answers’ regarding the implementation of the rules on clinical trials. Updates to this questions and answers document used to be presented and discussed within the “Expert group on...
The Directive 2022/642/EC requires the competent authority of the United Kingdom to publish on their website a list of medicinal products making use derogations under the European Commission Directive 2022/642. Read the updated list from Medicines...
Cross-border healthcare refers to healthcare received by a person outside of their Member State of affiliation. EU citizens have the right to receive healthcare in any EU country and to be partially or fully reimbursed...
The guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices addresses the classification of in vitro diagnostic medical devices and provides clarifications on the classification rules as set out...
The European Commission has published a template for notified body confirmation letter of the status of a formal application, written agreement, and appropriate surveillance in the framework of Regulation EU 2024/1860. Read the news announcement published...
The In Vitro Diagnostic Regulation (EU IVDR 2017/746) replaced the In Vitro Diagnostic Medical device Directive (EU IVDD 98/79/EC) and entered into force in 2017 with 26 May 2022 as date of application (DOA). Prior...
